Integrated implant

ABSTRACT

An implant having an integrated cutting broach and/or cutting burr. The integrated implant may be inserted without requiring separate steps for drilling and broaching bone. The integrated implant assembly may include an integrated implant, a flexible sheath, a delivery rod, and a delivery pin. The implant may have a core which may have any of a variety of cross-sectional geometries. A method for fusing bone may involve inserting the implant laterally through the ilium, through the sacral-iliac joint, and into the sacrum.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 14/719,274, titled “INTEGRATED IMPLANT,” filed May 21, 2015, whichis a divisional of U.S. patent application Ser. No. 13/791,746, titled“INTEGRATED IMPLANT,” filed Mar. 8, 2013, now U.S. Pat. No. 9,044,321,which claims priority to U.S. Provisional Patent Application No.61/609,221, titled “INTEGRATED IMPLANT,” filed on Mar. 9, 2012. Thispatent application may be related to one or more of the following patentapplications: U.S. Pat. No. 8,986,348, issued Mar. 24, 2015, titled“SYSTEMS AND METHODS FOR THE FUSION OF THE SACRAL-ILIAC JOINT,” and U.S.Pat. No. 8,425,570, issued Apr. 23, 2013, titled “APPARATUS, SYSTEMS,AND METHODS FOR ACHIEVING ANTERIOR LUMBAR INTERBODY FUSION”. Each ofthese references is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention generally relates to the fixation or fusion ofbone.

BACKGROUND

Many types of hardware are available both for the fixation of bones thatare fractured and for the fixation of bones that are to be fused. Afusion is an operation where two bones, usually separated by a joint,are allowed to grow together into one bone. The medical term for thistype of fusion procedure is arthrodesis.

For example, lumbar fusion procedures have been used in the treatment ofpain and the effects of degenerative changes in the lower back. Anexample of a lumbar fusion is a fusion in the S1-L5-L4 region in thespine.

Another example, the human hip girdle (see FIGS. 9 and 10) is made up ofthree large bones joined by two relatively immobile joints. One of thebones is called the sacrum and it lies at the bottom of the lumbarspine, where it connects with the L5 vertebra. The other two bones arecommonly called “hip bones” and are technically referred to as the rightilium and the left ilium. The sacrum connects with both hip bones at theleft and right sacroiliac joints (in shorthand, the SI-Joint).

The SI-Joint functions in the transmission of forces from the spine tothe lower extremities, and vice-versa. The SI-Joint has been describedas a pain generator for up to 22% of lower back pain.

To relieve pain generated from the SI Joint, sacroiliac joint fusion istypically indicated as a surgical treatment, e.g., for degenerativesacroiliitis, inflammatory sacroiliitis, iatrogenic instability of thesacroiliac joint, osteitis condensans ilii, or traumatic fracturedislocation of the pelvis. Currently, screws and screws with plates areused for sacro-iliac fusion. At the same time the cartilage has to beremoved from the “synovial joint” portion of the SI joint. This requiresa large incision to approach the damaged, subluxed, dislocated,fractured, or degenerative joint.

There is a need for improved bone fusion treatments for addressingchronic hip, joint or back pain.

SUMMARY OF THE DISCLOSURE

The present invention relates to the fixation or fusion of bone.

Some embodiments provide for an integrated implant delivery assemblyhaving an integrated bone fusion implant having a core and a cuttingbroach at a distal end of the core; a delivery rod; a delivery pin; anda flexible sheath. In some embodiments, a cannula extends through thedelivery rod and the implant. In some embodiments, the implant includesa socket at a proximal end configured to engage a threaded distal end ofthe delivery rod.

In any of the preceding embodiments, the delivery pin is adapted toslide through a cannula extending through the delivery rod and theimplant. The delivery pin can be configured to removably slide throughthe cannula. In some variations, the delivery pin is permanentlyattached to the implant. The delivery pin can be retractable in somecases. Additionally, the delivery pin can be configured to releasablyattach to a distal end of the implant. In some variations, the deliverypin is adapted to disengage and slip into an interior of the implant.The delivery pin may have a length between about 5 mm to about 30 mm. Inany of the preceding embodiments, a portion of the length of thedelivery pin extends distal of a distal end of the implant. The portionof length can be between about 5 mm to about 30 mm.

In any of the preceding embodiments, the flexible sheath is adapted toprotect soft tissue as the implant is advanced through bone, theflexible sheath having a plurality of outer wall portions forming apyramidal tip at a distal end of the sheath. The pyramidal tip may bepositioned at a distal end of the implant near the cutting broach. Insome cases, the outer wall portions are angled at 60 degrees to formvertices of the pyramidal tip. In any of the preceding embodiments, theflexible sheath includes a tapered distal tip.

In any of the preceding embodiments, the broach is coupled to the core.In some embodiments, the broach includes a plurality of cutting edgeslocated on a tapered distal end of the broach. In further embodiments,the broach includes teeth adapted to remove bone material as the implantis inserted through bone. In any of the preceding embodiments, theimplant includes an outer surface having surface features configured topromote bony in-growth on the implant. In some embodiments, the surfacefeatures include fenestrations. In some variations the outer surface ofthe implant is porous. In any of the preceding embodiments, the surfacefeatures extend longitudinally along the outer surface between aproximal end and a distal end of the implant. In any of the precedingembodiments, the surface features include longitudinally extendingridges adapted to contact the two bones. In some cases, the surfacefeatures include a porous plasma spray coating. In other embodiments,the surface features include a surface coating having a biologic aid forpromoting bony in-growth. A biologic aid includes growth factors or acontrolled release formulation.

In any of the preceding embodiments, the implant includes a geometricconfiguration adapted to resist loosening during movement. The geometricconfiguration may be a triangular cross-section, rectilinearcross-section, or curvilinear cross-section.

In any of the preceding embodiments, the delivery rod includes aprotrusion configured to control advancement through bone. In any of thepreceding embodiments, the implant includes a safety protrusionconfigured to indicate implant insertion depth. In some embodiments, theimplant includes a safety marking to indicate implant insertion depth.

Other embodiments provide for a bone fusion implant having a coreadapted for placement between two bones, the core having a first end anda second end; and a cutting broach at the second end of the core. Insome embodiments, the broach is coupled to the core. The broach mayinclude a plurality of cutting edges located on a tapered distal end ofthe broach. In some cases, the broach includes teeth adapted to removebone material as the implant is inserted through the two bones.

In any of the preceding embodiments, the implant includes an outersurface having surface features configured to promote bony in-growth onthe implant. In some embodiments, the surface features includefenestrations. In some variations the outer surface of the implant isporous. In any of the preceding embodiments, the surface features extendlongitudinally along the outer surface between a proximal end and adistal end of the implant. In any of the preceding embodiments, thesurface features include longitudinally extending ridges adapted tocontact the two bones. In some cases, the surface features include aporous plasma spray coating. In other embodiments, the surface featuresinclude a surface coating having a biologic aid for promoting bonyin-growth. A biologic aid includes growth factors or a controlledrelease formulation.

In any of the preceding embodiments, the implant includes a socket onthe first end of the core, the socket adapted to couple to a deliverytool configured to deliver the implant into bone.

In any of the preceding embodiments, the implant includes a delivery pinpermanently attached to the implant. In some cases, the delivery pin isretractable. In other cases, the delivery pin has a length between about5 mm to about 30 mm. In some cases, a portion of the length of thedelivery pin extends distal of a distal end of the implant. The portionof length may be between about 5 mm to about 30 mm.

In any of the preceding embodiments, the implant may include a deliverypin configured to releasably attach to a distal end of the implant. Insome cases, the delivery pin is adapted to disengage and slip into aninterior of the implant.

In any of the preceding embodiments, the implant includes a geometricconfiguration adapted to resist loosening during movement. The geometricconfiguration may be a triangular cross-section, rectilinearcross-section, or curvilinear cross-section.

In any of the preceding embodiments, the implant has a length betweenabout 30 mm to about 70 mm.

In any of the preceding embodiments, the implant includes a safetyprotrusion configured to indicate implant insertion depth. In someembodiments, the implant includes a safety marking to indicate implantinsertion depth.

Further embodiments provide for an integrated implant delivery assemblyhaving a bone fusion implant including a core; a cutting broach at adistal end of the core; and a cutting burr having a cutting assemblyconfigured to remove and cut through bone; and a delivery pin assemblyhaving a delivery pin and a driving device, the delivery pin assemblyconfigured to be partially received within the cutting burr torotationally drive the cutting burr.

In any of the preceding embodiments, the driving device and the deliverypin are separate interlocking components. In some cases, the drivingdevice and the delivery pin are fused to form a single component. Inother variations, the length of the driving device is between about 30mm and 150 mm. In further embodiments, the delivery pin is configured tobe slidably received within a cannula of the cutting burr, the deliverypin adapted to extend distally from a distal end of the cutting burr.

In any of the preceding embodiments, the driving device includes a drivesocket; drive shaft, and a drive member configured to engage an implantsocket at a proximal end of the implant to rotationally lock therewith.The driving member can be configured to rotationally drive the cuttingburr when engaged with the implant socket.

In any of the preceding embodiments, the delivery pin includes a pinsocket configured to engage with the drive member of the driving deviceand a pin shaft extending distally from the pin socket. In some cases,the pin socket is configured to be rotationally driven by the drivingdevice when engaged with the drive member. In further embodiments, thepin socket includes a tapered distal point. In other variations, thelength of the pin shaft is about 30 mm to about 90 mm. In any of thepreceding embodiments, the pin shaft extends beyond a distal end of thecutting burr by a length between about 5 mm to about 30 mm.

In any of the preceding embodiments, the drive socket is configured toreceive a drill member, the drill member coupled to a draft shaft and adrill. The drill may be an impact drill. The drill shaft may beconfigured to rotationally drive the drill member to therebyrotationally drive the driving device while the drill member is engagedin the drive socket.

In any of the preceding embodiments, the cutting burr is positionedalong a central axis of the implant and extends through the core and thecutting broach. The cutting burr can be configured to rotate whilepositioned inside the core. In some variations, the cutting burr isconfigured to rotate while positioned inside the cutting broach. Infurther variations, the cutting burr is configured to be collapsible andremovable by retraction.

In any of the preceding embodiments, the cutting burr includes anexpanded configuration and a collapsed configuration, the cutting burradapted to transition to the collapsed configuration by retraction. Inany of the preceding embodiments, the cutting burr is adapted to extendbeyond a distal end of the implant. In any of the preceding embodiments,the cutting burr is adapted to extend a length between about 5 mm toabout 20 mm beyond the distal end of the implant.

In any of the preceding embodiments, the cutting assembly includes a setof centrifugal blades, the blades having an expanded state and aretracted state, the blades extending beyond a distal end of the implantin the expanded state and the blades retracted inward of the distal endof the implant in the retracted state.

In any of the preceding embodiments, the cutting assembly includes aplurality of cutting blades extending radially outward from the centerof the cutting assembly. In any of the preceding embodiments, theplurality of cutting blades are hinged to thereby expand and collapsethe cutting assembly. In any of the preceding embodiments, the cuttingblades are configured to bore through bone.

Further embodiments provide for a bone fusion implant having a corehaving a first end and a second end; a cutting broach at the second endof the core; and a cutting burr having a cutting assembly configured toremove and cut through bone.

In any of the preceding embodiments, the cutting burr is positionedalong a central axis of the implant and extends through the core and thecutting broach. In some cases, the cutting burr is configured to rotatewhile positioned inside the core. In any of the preceding embodiments,the cutting burr is configured to rotate while positioned inside thecutting broach. Additionally, the cutting burr may be fixedtranslationally on a center axis of the implant.

In any of the preceding embodiments, the cutting burr includes anexpanded configuration and a collapsed configuration, the cutting burradapted to transition to the collapsed configuration by retraction. Inany of the preceding embodiments, the cutting burr is adapted to extendbeyond a distal end of the implant. In any of the preceding embodiments,the cutting burr is adapted to extend a length between about 5 mm toabout 20 mm beyond the distal end of the implant. In any of thepreceding embodiments, the cutting burr is configured to be collapsibleand removable by retraction.

In any of the preceding embodiments, the cutting burr further includes asocket positioned at a proximal end of the cutting burr; a cannulaextending between the cutting assembly and the socket, and a shaftcoupled to the socket and residing in the cannula. In some embodiments,the socket includes an interior surface having a square or hexagonshape. The socket may be configured with an interior surface adapted tofit and receive a driving device. In further embodiments, the socket isconfigured to impart a rotational driving force from the driving deviceto the shaft.

In any of the preceding embodiments, the shaft includes a channeladapted to move bone debris into an interior of the implant.

In any of the preceding embodiments, the cutting assembly includes aplurality of cutting blades extending radially outward from the centerof the cutting assembly. In any of the preceding embodiments, theplurality of cutting blades are hinged to thereby expand and collapsethe cutting assembly. In any of the preceding embodiments, the cuttingblades are configured to bore through bone.

In any of the preceding embodiments, the broach is coupled to the core.The broach may include a plurality of cutting edges located on a tapereddistal end of the broach. Additionally, the broach may include teethadapted to remove bone material as the implant is inserted through thetwo bones.

In any of the preceding embodiments, the implant includes an outersurface having surface features configured to promote bony in-growth onthe implant. In some embodiments, the surface features includefenestrations. In some variations the outer surface of the implant isporous. In any of the preceding embodiments, the surface features extendlongitudinally along the outer surface between a proximal end and adistal end of the implant. In any of the preceding embodiments, thesurface features include longitudinally extending ridges adapted tocontact the two bones. In some cases, the surface features include aporous plasma spray coating. In other embodiments, the surface featuresinclude a surface coating having a biologic aid for promoting bonyin-growth. A biologic aid includes growth factors or a controlledrelease formulation.

In any of the preceding embodiments, the implant includes a socket onthe first end of the core, the socket adapted to couple to a deliverytool configured to deliver the implant into bone.

In any of the preceding embodiments, the implant may include a deliverypin permanently attached to the implant. In some cases, the delivery pinis retractable. The delivery pin may have a length between about 5 mm toabout 30 mm. In some cases, the delivery pin is configured to releasablyattach to a distal end of the implant. In any of the precedingembodiments, the delivery pin is adapted to disengage and slip into aninterior of the implant. In any of the preceding embodiments, the pinmay extend beyond a distal end of the cutting burr by a length betweenabout 5 mm to about 30 mm.

In any of the preceding embodiments, the implant may include geometricconfiguration adapted to resist loosening during movement. These includea triangular, rectilinear, and curvilinear cross-section.

In any of the preceding embodiments, the implant may include a safetyprotrusion configured to indicate implant insertion depth. In any of thepreceding embodiments, the implant may include a safety marking toindicate implant insertion depth.

Further embodiments provide for a bone fusion implant having a corehaving a hollow structure formed by a multi-sided wall; a delivery pinhole within the core extending from a proximal end to a distal end ofthe core; and a plurality of cutting edges at a distal end of themulti-sided wall.

In any of the preceding embodiments, the multi-sided wall includes aplurality of interlocking wall sections. In some cases, the plurality ofinterlocking wall sections include interlocking edges, the wall sectionsconfigured to be implanted independently and interlocked after insertioninto a patient. In any of the preceding embodiments, the multi-sidedwall has a thickness between about 0.5 mm to about 5 mm. In any of thepreceding embodiments, the multi-sided wall is formed from a pluralityof wall portions, each wall portion having a tapering distal end. In anyof the preceding embodiments, the tapering distal end forms a point atthe center of the tapering distal end of each wall portion. In any ofthe preceding embodiments, the tapering distal end forms a vertexbetween intersecting wall portions. In some embodiments, the taperingdistal end forms a jagged cutting edge at the distal end of themulti-sided wall.

In any of the preceding embodiments, the surface area of the implantgradually increases with distance moving from the tapering distal endtoward a proximal end of the implant.

In any of the preceding embodiments, the cutting edges are corrugated ortapered. In any of the preceding embodiments, the cutting edges arepositioned on an interior surface of the multi-sided wall. In otherembodiments, the cutting edges are configured to cut bone and pass cutbone through the core.

In any of the preceding embodiments, the core is formed from three wallportions having a first hollow triangular member, a second hollowtriangular member, and a connecting member attached to the first andsecond triangular members. In some cases, wherein the first and secondmembers are coupled together at an apex point for each triangularmember.

In any of the preceding embodiments, the implant includes a bow-tieshaped cross-section.

In any of the preceding embodiments, the thickness of the three wallportions is between about 0.5 mm to about 5 mm.

In any of the preceding embodiments, the length of the implant isbetween about 30 mm to about 70 mm.

In any of the preceding embodiments, the implant includes an I-shapedcross-section.

In any of the preceding embodiments, the core is formed from three wallportions having a first elongate member, a second elongate member, and athird elongate member, the first and second members positionedrelatively parallel to one another and the third elongate memberintersecting the first and second members to couple the three memberstogether.

In any of the preceding embodiments, the third elongate memberperpendicularly intersects the first and second members.

In any of the preceding embodiments, the implant has a tri-leggedcross-section. In any of the preceding embodiments, the implant has aT-shaped cross-section. In any of the preceding embodiments, the implanthas a X-shaped cross-section. In any of the preceding embodiments, theimplant has a rectilinear cross-section. In any of the precedingembodiments, the implant has a curved cross-section.

Further embodiments describe methods for fusing bone. These methodsinclude identifying a bone site having a first bone segment, a secondbone segment, and a non-bony region between the first and second bonesegments; providing a bone fusion implant having a core with a distalend and cutting broach on the distal end of the core; inserting adelivery pin through a first bone segment and into a second bonesegment, wherein the delivery pin is inserted partially through thesecond bone segment; forming a pilot insertion bore in the first andsecond bone segments; and inserting the implant into the first andsecond bone segments to thereby fuse the bone segments, whereininserting the implant advances the cutting broach through the bore andcuts at least one edge of the bore to accommodate the implant shape.

In any of the preceding embodiments, the method may include insertingthe implant entirely through the first bone segment and non-bony regionand partially through the second bone segment.

Additionally, any of the preceding embodiments may include passing acannulated drill bit over the delivery pin and forming the pilotinsertion bore with the cannulated drill.

In any of the preceding embodiments, the implant further includes acutting burr on the distal end of the core.

In any of the preceding embodiments, forming a pilot insertion boreincludes advancing the cutting burr into the first and second bonesegments.

Additionally, any of the preceding embodiments may include generatingthe pilot insertion bore by tapping the implant into the first andsecond bone segments.

In any of the preceding embodiments, inserting the implant furtherincludes tapping a delivery rod engaged with the implant to form a pilotinsertion bore with the cutting burr.

Additionally, any of the preceding embodiments may include rotationallydriving the cutting burr to form the pilot insertion bore.

Additionally, any of the preceding embodiments may include retractingthe cutting bore into an interior of the implant.

Additionally, any of the preceding embodiments may include an implantwith a triangular cross-section.

Additionally, any of the preceding embodiments may include an implantwith an I-shaped cross-section.

In any of the preceding embodiments for fusing bone, the first bonesegment is the ilium and the second bone segment is the sacrum.

In any of the preceding embodiments for fusing bone, the steps mayinclude inserting the implant laterally through the ilium and into thesacrum.

In any of the preceding embodiments for fusing bone, the steps mayinclude inserting a plurality of implants laterally through the iliumand into the sacrum.

Additional embodiments provide for methods for fusion of thesacral-iliac joint between an iliac and a sacrum. These methods includeproviding an integrated implant delivery assembly and a delivery pin;inserting the delivery pin laterally through the ilium and into thesacrum; sliding the flexible sheath over the delivery pin to protectsoft tissue around the delivery pin; tapping the implant into the ilium,through the sacral-iliac joint, and into the sacrum.

In any of the preceding embodiments, the assembly may include a flexiblesheath and a bone fusion implant having a core and a cutting broach on adistal end of the core.

In any of the preceding embodiments, the method may include forming apilot insertion bore by the tapping the implant into the ilium, throughthe sacral-iliac joint, and into the sacrum.

In any of the preceding embodiments, the method may include broachingthe bore by advancing the implant through the bore. In any of thepreceding embodiments, the implant further includes a cutting burr atthe distal end of the core.

In any of the preceding embodiments, the method may include rotationallydriving the cutting burr to generate a pilot insertion bore. In any ofthe preceding embodiments, the method may include retracting the cuttingburr inside the implant after generating the bore.

In any of the preceding embodiments, the method may include positioningthe implant to be flush with a lateral wall of the ilium. In any of thepreceding embodiments, the method may include positioning a proximal endof the implant to extend about 1 mm to about 5 mm outside of the ilium.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A is a longitudinal section view of an exemplary integratedimplant assembly.

FIG. 1B is an enlarged front view of the distal end of a flexible sheathof FIG. 1A.

FIG. 1C is an enlarged front view of the distal end of the integratedimplant of FIG. 1A.

FIG. 2A is a longitudinal sectional view of another exemplary integratedimplant.

FIG. 2B is an enlarged front view of the distal end of the integratedimplant of FIG. 2A.

FIG. 3 is a side view of an integrated delivery pin assembly.

FIGS. 4A-F are isometric views of exemplary hollow integrated implants.

FIG. 5 is a front view of another hollow integrated implant.

FIG. 6A is a front view of another integrated implant.

FIG. 6B is a perspective view of the integrated implant of FIG. 6A.

FIGS. 7A-M are illustrations of cross-sectional geometries of exemplaryintegrated implants.

FIGS. 8A-8D are illustrations of an exemplary procedure for implantingthe integrated implant of FIG. 1A.

FIGS. 9-10 are, respectively, anterior and posterior anterior views ofthe human hip girdle comprising the sacrum and the hip bones (the rightilium, and the left ilium), the sacrum being connected with both hipbones at the sacroiliac joint (in shorthand, the SI-Joint).

FIGS. 11-13B are anatomic views showing, respectively, in pre-implantedperspective, implanted perspective, implanted anterior view, andimplanted cranio-caudal section view, the implantation of three implantstructures for the fixation of the SI-Joint using a lateral approachthrough the ilium, the SI-Joint, and into the sacrum.

FIGS. 14A-D are anatomic views of implanted exemplary integratedimplants.

DETAILED DESCRIPTION

Reference will now be made in detail to exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with theexemplary embodiments, it will be understood that they are not intendedto limit the invention to those embodiments. On the contrary, theinvention is intended to cover alternatives, modifications andequivalents, which may be included within the spirit and scope of theinvention as described herein.

Various aspects of the present invention relate to an integrated implanthaving a cutting broach and/or cutting burr. In various embodiments, theintegrated implants may be used to fuse the sacroiliac joint. Integratedimplants discussed herein may also be used to fuse other bones within ahuman patient. For example, the integrated implant may be used to fusethe lumbar region of the spine and other bones. As such, those ofordinary skill in the art will realize that exemplary embodimentsrelated to sacroiliac joint fusion are not limited to this type offusion, but rather set forth as examples.

FIG. 1A is a longitudinal sectional view of an exemplary integratedimplant assembly. The integrated implant assembly 10 includes anintegrated implant 20, a flexible sheath 22, a delivery rod 24, and adelivery pin 26. Delivery rod 24 and integrated implant 20 may becannulated. Canula 32 may provide access for the delivery pin 26. Thedelivery rod 24 may include a threaded distal end 25 that may have aradius that is smaller than the radius of the delivery rod 24. Thethreaded distal end 25 may engage the integrated implant socket 21.Integrated implant 20 may include a socket 21, core 28 and a cuttingbroach 30. The core 28 may have a proximal end and a distal end, wherethe terms distal and proximal are used with respect to outer end of thedelivery rod (the portion of the delivery rod that does not engage theintegrated implant socket 21). The distal end of the core 28 is coupledto the cutting broach 30. The cutting broach 30 may eliminate the needto take additional steps of drilling and broaching the bone or broachingthe bone in an independent step. In various embodiments, the cuttingbroach 30 may be coupled to the core 28 by welding, independentfasteners, press-fit, threads, or other methods. In various embodiments,the cutting broach 30 and the core 28 may be generated as a single pieceby machining, molding, extrusion or other methods.

Integrated implant 20 may be formed from a durable material usable inthe prosthetic arts that is not subject to significant bio-absorption orresorption by surrounding bone or tissue over time. Integrated implant20 is intended to remain in place for a time sufficient to stabilize thefracture or fusion site. Integrated implant 20 may also remain in placein the patient permanently. Such materials include, but are not limitedto, titanium, titanium alloys, tantalum, tivanium (aluminum, vanadium,and titanium), chrome cobalt, surgical steel, or any other total jointreplacement metal and/or ceramic, sintered glass,⋅ artificial bone, anyuncemented metal or ceramic surface, or a combination thereof.Alternatively, the integrated implant 20 may be formed from a suitabledurable biologic material or a combination of metal and biologicmaterial, such as a biocompatible bone-filling material. The integratedimplant 20 may be molded from a flowable biologic material, e.g.,acrylic bone cement, that is cured, e.g., by UV light, to a non-flowableor solid material. e.g. polymers such as PLA, PLGA, PGA, or othersimilar materials.

The integrated implant 20 may be sized according to the local anatomy.The morphology of the local structures can be generally understood bymedical professionals using textbooks of human skeletal anatomy alongwith their knowledge of the site and its disease or injury. Thephysician is also able to ascertain the dimensions of the appropriatelysized integrated implant 20 based upon prior analysis of the morphologyof the targeted bone region using, for example, plain film x-ray,fluoroscopic x-ray, or MRI or CT scanning, as well as intraoperativesizing methods using provided instrumentation. In various embodiments,the length of the integrated implant L_(I) is in the range of about 30mm to 70 mm. In various embodiments, the length of the integratedimplant L_(I) is about 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm,65 mm, and 70 mm.

The integrated implant 20 may take various shapes and have variouscross-sectional geometries. The integrated implant 20 may have agenerally curvilinear (e.g., round or oval) cross-section or a generallyrectilinear cross section (e.g., square or rectangular or triangular) orcombinations thereof. The shape of integrated implant 20 is furtherdiscussed with respect to FIGS. 4-7M.

In FIGS. 1A and 2A, the integrated implants 20, 50 are illustrated witha triangular shape, which may effectively improve implant stability.Implant stability may be defined as the ability of the implant to resistloads in the axial, lateral and rotational directions without loosening.The ability of the implant to withstand these loads while maintainingthe stability is important. Primary implant stability is achieved at thetime of surgery and may depend on the implant design. Primary implantstability may be influenced by implant geometry. An implant having atriangular geometry may resist rotation, migration and micromotion onceimplanted and may provide advantages over other geometries. While theinitial stability may be related to mechanical features, the bonehealing process eventually dictates long-term stability.

Secondary implant stability, which is achieved over time, may depend onthe level of primary stability and the biological response to thesurgery and implant. Newly formed bone tissue may fill voids at theimplant/bone interface, create direct contact with the implant surface,and engage with surface irregularities. This interlocking effect isamplified when the newly formed bone matures over time.

The outer surface of the integrated implant 20 may have longitudinalchannels that extend from the distal end to the proximal end. In variousembodiments, the outer surface of the integrated implant 20 iscorrugated having a series of parallel ridges and furrows (not shown)that extend longitudinally between the proximal and distal ends. Thechannels, corrugations and furrows may increase the bony contact areabetween the bones and implant 20

Additionally, integrated implant 20 may have a portion on the outersurface that is conducive to bony in-growth, on-growth, orthrough-growth. In various embodiments, the portion may include theentire outer surface of the integrated implant 20. The bony in-growth,on-growth, or through-growth portion may include through holes, varioussurface patterns, various surface textures, and/or pores, orcombinations thereof. In various embodiments, the outer surface may havea mesh configuration, beaded configuration, trabecular configuration,holes or fenestrations or any surface conducive to bony through-growth.

The outer surface of the integrated implant 20 may be coated, wrapped orsurface treated to promote the bony in-growth or through-growth. Invarious embodiments, the coating material can include a biologic aidthat can promote and/or enhance bony ingrowth, tissue repair, and/orreduce inflammation, infection and pain. The biologic aid may includegrowth factors, such as bone morphogenetic proteins (BMPs),hydroxyapatite in a liquid or slurry carrier, demineralized bone,morselized autograft or allograft bone, medications to reduceinflammation, infection and pain such as analgesics, antibiotics andsteroids. In various embodiments, the growth factors may be humanrecombinant growth factors, such as rh-BMP-2 and/or rh-BMP-7, or anyother human recombinant form of BMP. The carrier for the biologic aidmay be a liquid or gel such as saline or a collagen gel. The biologicaid may also be encapsulated or incorporated in a controlled releasedformulation so that the biologic aid is released to the patient at theimplant site over a longer duration. For example, the controlled releaseformulation may be configured to release the biologic aid over thecourse of days, weeks or months, and can be configured to release thebiologic aid over an estimated time it would take for the implant siteto heal. The amount of biologic aid delivered to the integrated implant20 may be controlled using a variety of techniques, such as controllingor varying the amount of coating material applied to the integratedimplant 20 and/or controlling or varying the amount of biologic aidincorporated into the coating material. Controlling the amount ofbiologic aid delivered may be important because excessive use of certainbiologic aids may result in negative effects such as localizedinflammation, local pain, or radicular pain.

In a various embodiments, the bony in-growth portion, on-growth, orthrough-growth portion comprises a porous plasma spray coating on theintegrated implant 20. The coating may create a biomechanically rigorousfixation/fusion system, designed to support reliable fixation/fusion andacute weight bearing capacity.

Alternatively, the outer surface may be formed from a material thatitself inherently possesses a structure conducive to bony in-growth orthrough-growth, such as a porous mesh, hydroxyapetite, or other poroussurface.

The bony in-growth or through-growth portion may further be covered withvarious other coatings such as antimicrobial, antithrombotic, andosteoinductive agents, or a combination thereof. In various embodiments,the entire integrated implant 20 may be impregnated with such agents.

The delivery pin 26 of the integrated implant assembly 10 shown in FIG.1A may have a pointed or blunt tip at the distal end. The delivery pin26 may be permanently attached to the integrated implant 20. Thepermanently attached delivery pin 26 may be retractable or may disengageand slip inside the integrated implant 20. Alternatively, the deliverypin 26 may be removable. In various embodiments, the delivery pin 26 maybe part of the integrated implant 20 or part of a delivery rod 24. Invarious embodiments, the length L_(P) of the delivery pin 26 is in therange of about 0 mm to 30 mm. In various embodiments, the length L_(P)of the delivery pin 26 is about 0 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mmand 30 mm. In various embodiments, the length L_(P) of the delivery pin26 extends beyond the distal end of the integrated implant 20 by adistance of about 0 mm to 30 mm. In various embodiments, the lengthL_(P) of the delivery pin 26 extends beyond the distal end of theintegrated implant 20 by a distance of about 0 mm, 5 mm, 10 mm, 15 mm,20 mm, 25 mm, and 30 mm.

FIG. 1B is an enlarged front view of the distal end of a flexible sheathof FIG. 1A. The flexible sheath 22 may be used as a delivery sheath thatmay protect soft tissue as the integrated implant 20 is advanced. Theflexible sheath 22 may have a tip formed at the distal end that forcesexpansion when it is tapped against bone. The design of the tip of theflexible sheath 22 may provide easy insertion through soft tissue. Theflexible sheath 22 includes outer wall portions 34. Outer wall portions34 can be angled at, for example, approximately 60 degrees to formvertices of a triangle. The outer wall portions 34 may be substantiallyplanar forming a pyramidal tip at the distal end. The flexible sheathmay be formed from one or more of a thermoplastic polyethylene (e.g.ultra-high molecular weight polyethylene, high-modulus polyethylene orhigh-performance polyethylene), organic polymer thermoplastic (e.g.polyether ether ketone), thermoset polymer, elastomer and othermaterial.

FIG. 1C is an enlarged front view of the distal end of the integratedimplant of FIG. 1A. The integrated implant 20 includes delivery pin 26,core 28, cutting broach 30 and canula 32. Cutting broach 30 may includebroaching edges 36. The broaching edges 36 may be located on a tapereddistal end of the cutting broach 30. The broaching edges 36 may includeteeth used to remove bone material when the integrated implant 20 isinserted linearly.

In various embodiments, integrated implant assembly 10 includes acannulated delivery rod 24 and cannulated integrated implant 20 that isused with a standard delivery pin 26, for example a Steinman pin. Invarious embodiments, the integrated implant assembly 10 includes adelivery pin 26 that is coupled to the integrated implant 20. There maybe no canula 32 within integrated implant 20 or delivery rod 24. Invarious embodiments, integrated implant assembly 10 includes a deliveryrod 24 and a cannulated integrated implant 20. Delivery rod 24 may becoupled to delivery pin 26.

FIG. 2A is a longitudinal sectional view of another exemplary integratedimplant. The integrated implant 50 of FIG. 2A includes core 28 andcutting broach 30 of FIGS. 1A and 1C. The integrated implant 50 may alsobe coupled to a cutting burr 38. Cutting burr 38 may have a canula 32,and may include socket 40, shaft 42, and cutting assembly 46. Thecutting burr 38 may be formed from the same materials as integratedimplant 20 of FIG. 1A. Cutting burr 38 may extend between the proximalend 41 and the distal end 43 of the integrated implant 50 and may bepositioned within the integrated implant 50, for example along thecenter axis of the integrated implant 50. In various embodiments, thecutting burr 38 is part of the integrated implant structure andconfigured to move rotationally while within the center of theintegrated implant 50. In various embodiments, the cutting burr 38 isfixed translationally within the center of the integrated implant 50.When the cutting burr 38 is part of the integrated implant 50, thecutting burr 38 may remain implanted.

In various embodiments, the cutting burr 38 is collapsible and removableby retraction. Cutting burr 38 may extend beyond the distal end ofintegrated implant 50. In various embodiments, the cutting burr 38 mayextend beyond the distal end of the integrated implant 50 a distance inthe range of about 0 mm and 20 mm. In various embodiments, may extendbeyond the distal end of the integrated implant 50 a distance of 0 mm, 5mm, 10 mm, 15 mm, and 20 mm.

Socket 40 is positioned at the proximal end of the cutting burr 38 andmay include an opening or a hollow cavity into which an inserted part isdesigned to fit. The interior surface of the socket 40 may form ageometrical shape such as a square, hexagon or other geometrical shape.In various embodiments, the interior surface of socket 40 is designed tofit and receive a driver or driving device. Socket 40 may be coupled tothe shaft 42 for imparting a rotational driving force from a driver toshaft 42. The shaft 42 may extend longitudinally from the distal end ofthe socket 40 to the proximal end of the cutting assembly 46.

Cutting assembly 46 may include an arrangement of a plurality of cuttingblades 48 (shown in FIG. 2B) that extend radially outward and that maybe mounted for rotation about a central axis. During operation, thecutting blades 48 may extend outward in front of the cutting broach 30to remove and cut through bone. The cutting blades 48 may be hinged sothat they are expandable and collapsible. The cutting blades 48 may beattached to a flange. The cutting blades 48 may be retracted inside ofthe integrated implant 50 after bone removal is complete. One or morechannels may be provided in shaft 42 and/or in core 28 to permit bonechips created by cutting blades 48 to move away from the cutting areaand into the integrated implant. The removed bone chips may be evacuatedfrom the implant by the used of helical flutes, suction, gas pressure,introduction of irrigation fluid, and/or other means. Integrated implant50 may be configured such that some or all of the cut bone chips remainwithin the implant and/or are directed to surface portions of theimplant to aid in healing and bony-ingrowth into the implant.

Generally, the cutting broach 30 may be used to cut pointed or angulatedcorners of bone and the cutting burr 38 may be used to cut the maindiameter of bone. The core 28, cutting broach 30 and cutting burr 38 ofintegrated implant 50 may be formed in a similar manner to that ofintegrated implant 20 of FIG. 1A-C. The formation may includeconstructing an integrated implant from a similar material and using asimilar molding and sizing process as described with respect to FIG.1A-C.

FIG. 2B is an enlarged front view of the distal end of the integratedimplant of FIG. 2A. The integrated implant 50 includes core 28, cuttingbroach 30, cutting burr 38 and canula 32. Cutting broach 30 may includebroaching edges 36. The broaching edges 36 may be located on a tapereddistal end of the cutting broach 30. The broaching edges 36 may includeteeth used to remove bone material when the integrated implant 50 isinserted linearly. Cutting burr 38 may include cutting assembly 46 withcutting blades 48 to bore through the bone.

FIG. 3 is a side view of an integrated delivery pin assembly. Theintegrated delivery pin assembly 100 may include driving device 52 and adelivery pin 54. The driving device 52 may include a drive socket 56,drive shaft 58, and drive member 60. The delivery pin 54 may include apin socket 62 and pin shaft 64. The integrated delivery pin assembly 100of this embodiment is configured to be partially received within cuttingburr 38 to rotationally drive the cutting burr. Specifically, thedelivery pin 54 is configured to be slidably received within cannula 32of cutting burr 38 and to extend from the distal end of cutting burr 38,as depicted by the dashed lines in FIG. 2A. Drive member 60 isconfigured to be slidably received within implant socket 40, shown inFIG. 2A, and rotationally lock therewith. The drive socket 56 mayreceive or fit a drill member 66. The drill member 66 is coupled to adrill shaft 68 and drill (not shown). In various embodiments, the drillis an impact drill.

In various embodiments, the driving device 52 and delivery pin 54 may beseparate pieces that may be assembled. In operation, the drill shaft 68turns in a rotational direction which drives the drill member 66 in arotational direction. Drill member 66 engages drive socket 56 and drivesthe driving device 52 in a rotational direction. The interior surface ofthe drive socket 56 may form a geometrical shape such as a hexagon orother geometrical shape. A drive shaft 58 extends longitudinally betweenthe distal end of the drive socket 56 and proximal end of the drivemember 60. The drive member 60 may engage the pin socket 62.

Pin socket 62 is driven by the drive member 60 in a rotationaldirection. The interior surface of the pin socket 62 may form ageometrical shape such as a hexagon or other geometrical shape. Thedistal end of the pin socket 62 may be coupled to a pin shaft 64 thathas a length of L_(S). The distal end the pin shaft 64 may form a point.In various embodiments, the length L_(S) of pin shaft 64 is in a rangeof about 30 mm to 90 mm. In various embodiments, the length L_(S) of pinshaft 64 is about 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65mm, 70 mm, 75 mm, 80 mm, 85 mm, and 90 mm.

Delivery pin assembly 100 may be used to implant integrated implant 50.Delivery pin assembly 100 may be formed from one or more of variousmetals, metal alloys (e.g. stainless steel, titanium alloy), polymers,carbon fibers and other materials.

Alternatively, the driving device 52 and delivery pin 54 may be formedas a single piece or fused together to form a single piece. Inoperation, such as with integrated implant 50, an embodiment thatincludes a single driving member/delivery pin piece, the drill member 66may engage the drive socket 56 and may move the single piece in arotational direction. Drive socket 56 may be coupled to drive member 60.Drive member 60 may engage socket 40 on the proximal end of the cuttingburr 38 (shown in FIG. 2A) and may drive the cutting burr 38 in arotational direction.

In various embodiments, the length L_(S) of the pin shaft 64 extendsbeyond the distal end of the cutting burr 38 by a distance of about 0 mmto 30 mm. In various embodiments, the length L_(S) of the pin shaft 64extends beyond the distal end of the cutting burr 38 by a distance ofabout 0 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, and 30 mm. The lengthL_(S) of the pin shaft 64 may be specific to the length of theintegrated implant 50. The length L_(D) of the driving device 52 may bethe length which the integrated implant 50 will be driven into the bone.In various embodiments, the length L_(D) of driving device 52 is a rangeof about 30 mm and 150 mm. In various embodiments, the length L_(D) ofdriving device 52 is 30 mm, 60 mm, 90 mm, 120 mm, and 150 mm.

Integrated implants 20 and 50 may include a safety feature forpreventing the implant from being driven too far into a patient. Invarious embodiments, the safety feature may include a marking, aprotrusion, or some other feature on implants 20 and 50. The protrusionmay be located on delivery rod 24 or drill shaft 68 and may come incontact with a patient's skin or outer ilium surface to prevent furtheradvancement into the bone. The marking may be located on delivery rod 24or drill shaft 68 and may indicate a measure of the insertion depth, forexample depth gauge.

The integrated implant structures discussed with respect to FIGS. 4A-7Mmay be formed in a similar manner as integrated implant 20 of FIG. 1A-C.The formation may include constructing an integrated implant from asimilar material and using a similar molding and sizing process asdescribed with respect to FIG. 1A-C.

FIGS. 4A-E are side views of exemplary hollow integrated implants. Thehollow integrated implant 70 of FIG. 4E includes a core 72 made up ofthree wall portions 74. The core 72 may be formed as one multiple-sidedwall portion 74 or separate multiple interlockable wall portions 74. Invarious embodiments, multiple wall portions 74 are implantedindependently and assembled by interlocking the wall portion edges. Thedistal end 43 of wall portion 74 may have a cutting edge 76. A deliverypin hole 78 may be within core 72 and may extend between distal end 43and proximal end 41. In various embodiments, each delivery pin hole 78may be formed from a structure that may be soldered or otherwiseattached to an interior surface of a wall portion. In other embodiments,the delivery pin hole(s) may be integrally formed with the wallportion(s). The delivery pin hole(s) may be located at the edge(s) ofthe wall portion(s) and/or along the outside of the implant.

Cutting edges 76 may be implemented as a corrugated edge, razor edge,serrated edge or some other cutting edge. In various embodiments, thecutting edges 76 are tapered (See FIG. 4B). The cutting edges 76 mayextend along a portion of distal end 43. For example, the cutting edges76 may be positioned on the interior surface of wall portions 74 at thedistal end 43 (not shown). Wall portions 74 having cutting edges 76 maybe configured to cut through bone and allow the bone to pass through thehollow structure formed by wall portions 74.

Wall portions 74 may have fenestrations 80 conducive to bony in-growth.(See FIG. 4C) In various embodiments, wall portions 74 may be corrugatedalong the entire surface between the proximal end 41 and distal end 43.(See FIG. 4D) The exterior surface of wall portions 74 may be porous topromote bony in-growth or on-growth. In various embodiments, thethickness of the wall of wall portions 74 is about 1 mm. In variousembodiments, the thickness of wall portions 74 is in the range of about0.5 mm to 5 mm. In various embodiments, the length of integrated implant70 is in the range of about 30 mm to 70 mm. In various embodiments, thelength of the integrated implant 70 is about 30 mm, 35 mm, 40 mm, 45 mm,50 mm, 55 mm, 60 mm, 65 mm, and 70 mm.

In various embodiments, the distal end 43 of each wall portion 74 maytaper to one or more points. The integrated implants of FIG. 4E and FIG.4F illustrate exemplary embodiments which include cutting edges 76, acore 72 and three wall portions 74 with tapered distal ends 82. Invarious embodiments, each of the tapered distal ends 82 form a point inthe center of the distal end 43 of each wall portion 74 (FIG. 4E), or atthe apexes of the triangular cross-section (FIG. 4F). The tapered distalends 82 provide a gradually increasing surface area to facilitatedriving the core 72 into bone.

FIG. 5 is a front view of another hollow integrated implant. The hollowintegrated implant 100 includes wall portions 74, cutting edges 76 anddelivery pin holes 78. Wall portions 74 may form a hollow shape similarto an I-beam. Each half of the I-beam may be formed by three wallportions 74 forming a triangle. The two triangles may be coupledtogether at an apex point for each triangle. An additional wall portion75 may connect the two triangles on each side of the connected apexpoints. The two triangles couple together at an apex point to form abow-tie shaped configuration. The thickness of the wall of wall portions74 and 75 may be about 1 mm. In various embodiments, the thickness ofwall portions 74 and 75 is in the range of about 0.5 mm to 5 mm. Invarious embodiments, the length of integrated implant 100 is in therange of about 30 mm to 70 mm. In various embodiments, the length of theintegrated implant 100 is about 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55mm, 60 mm, 65 mm, and 70 mm.

The cutting edges 76 may be implemented on one or more of the wallportions 74. In various embodiments, each wall portion 74 may include acutting edge 76. Each cutting edge 76 may be implemented as any of thecutting edges discussed with respect to FIGS. 4A-E.

The hollow integrated implant 100 may include one or more delivery pins78. Each delivery pin hole may be configured to receive a delivery pin.In various embodiments, each delivery pin hole 78 may be formed from astructure that may be soldered or otherwise attached to or formed in aninterior, middle or exterior region of a wall portion. Wall portions 74having cutting edges 76 may be configured to cut through bone and allowthe bone to pass through the hollow structure formed by wall portions74.

FIGS. 6A-B is a front view and perspective view, respectively, ofanother integrated implant. The hollow or open integrated implant 110includes wall portions 74 and cutting edges 76. Although no delivery pinhole 78 is illustrated, the integrated implant 110 may include one ormore delivery pin holes 78. Wall portions 74 may form an I-beam shape.The I-beam shape may be formed by three wall portions 74 forming aletter “I”. In various embodiments, the integrated implant 110, incontrast to an I-beam configuration used in building construction, maynot require right angles at the junction between the “I” wall portion 74and the top and bottom wall portions 74. (See FIG. 14B)

The cutting edges 76 may be implemented on one or more of the wallportions 74. In various embodiments, each wall portion 74 may include acutting edge 76. Each cutting edge 76 may be implemented as any of thecutting edges discussed with respect to FIGS. 4A-E. The thickness of thewall of wall portions 74 and 75 may be about 1 mm. In variousembodiments, the thickness of wall portions 74 and 75 is in the range ofabout 0.5 mm to 5 mm. In various embodiments, the length of integratedimplant 110 is in the range of about 10 mm to 70 mm. In variousembodiments, the length of the integrated implant 110 is about 30 mm, 35mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, and 70 mm.

FIGS. 7A-M are illustrations of cross-sectional geometries of exemplaryintegrated implants. Each of FIGS. 7A-M illustrate a geometry, adelivery pin hole and broaching edges.

FIG. 7A illustrates a tri-legged integrated implant. The integratedimplant of FIG. 7A includes three legs, which each leg having broachingedges towards the end of the leg. The integrated implant of FIG. 7Afurther includes a delivery pin hole at the center of the implant. FIG.7B illustrates a star shaped integrated implant having a plurality ofpoints, such as five points. Each point may include broaching edges, anda delivery pin hole may be located in the center of the star shapedintegrated implant.

FIG. 7C illustrates a T-shaped integrated implant. Each corner of theT-shaped integrated implant may include broaching edges. A delivery pinhole may be positioned within the T-shaped integrated implant in avariety of positions, such as for example centered along the horizontalportion of the T-shape. FIG. 7D illustrates a kite shaped or diamondshaped integrated implant having four points. Each point may includebroaching edges, and a delivery pin hole may be positioned in the centerof the kite or diamond shaped integrated implant.

FIG. 7E illustrates a curved end four-pointed star-shaped integratedimplant. The curved star-shaped integrated implant has four curvedextensions, each of which includes a broaching edge. A delivery pin holemay be located in the center of the star. The edges may be less roundedor more rounded than the star shaped implant illustrated in FIG. 7E.FIG. 7F illustrates a straight end four-pointed star-shaped or X-shapedintegrated implant. The straight star-shaped integrated implant has fourstraight extensions, each of which includes a broaching edge, and adelivery pin hole in the middle of the star.

FIG. 7G illustrates a dumbbell shaped integrated implant. The integratedimplant of FIG. 7G includes a delivery pin hole at the center and ateach the two ends of the implant. Each end may also have broachingedges. FIG. 7H illustrates a bean shaped integrated implant. The beanshaped integrated implant includes a delivery pin hole at the implantcenter and broaching edges at each of the two ends of the integratedimplant. FIG. 7I illustrates an S-shaped integrated implant having adelivery pin hole in the center and at each end. Broaching edges may belocated at the integrated implant ends.

FIG. 7J illustrates a square shaped integrated implant. The squareshaped implant includes broaching edges at each corner of the implant,and a delivery pin hole at the center of the square shape. FIG. 7Killustrates an oval shaped integrated implant having broaching edges atthe narrow ends of the oval and a delivery pin hole at the center of theoval. FIG. 7L illustrates a Z-shape integrated implant. The integratedimplant of FIG. 7L may include a delivery pin hole along the centervertical portion of the Z-shape as well as a delivery pin hole at one ormore ends. The broaching edges may be positioned at each end as well.FIG. 7M illustrates a V-shape integrated implant. The integrated implantof FIG. 7M may include a delivery pin hole at the top of the invertedV-shape shown as well as a delivery pin hole at one or more ends. Thebroaching edges may be positioned on one or more of the two V-shape endsas well.

FIGS. 8A-8D are illustrations of an exemplary procedure for implantingthe integrated implant of FIG. 1A. More detailed, anatomically-focuseddescriptions of particular implantation techniques of the integratedimplant 20 in the SI-Joint are described with respect FIGS. 9-13B.

The physician identifies the bone segments or adjacent bone regions thatare to be fixated or fused (arthrodesed) (see FIG. 8A). Aided byconventional visualization techniques, e.g., using X-ray imageintensifiers such as a C-arms or fluoroscopes to produce a live imagefeed that is displayed on a TV screen, a delivery pin 26 is introducedby conventional means (see FIG. 8B) through the one adjacent bonesegment or region (bone segment 1), through the intervening space orjoint, and partially into the other adjacent bone segment or region(bone segment 2).

A cannulated drill bit 90 may be passed over the delivery pin 26 (seeFIG. 8C), to form a pilot insertion path or bore 92 through the oneadjacent bone segment or region, through the intervening space or joint,and partially into the other adjacent bone segment or region. A singledrill bit or multiple drill bits 90 may be employed to drill throughbone fragments or bone surfaces to create a pilot bore 92 of the desiredsize and configuration. When the pilot bore 92 is completed, thecannulated drill bit 90 is removed.

An integrated implant 20, which is triangular in the illustratedembodiment (see FIG. 8D), is tapped over the delivery pin 26 through thepilot bore 92. The integrated implant 20 cuts along the edges of thepilot bore 92 to form the desired profile to accommodate the geometry ofthe integrated implant 20 through the one adjacent bone segment orregion, through the intervening space or joint, and partially into theother adjacent bone segment or region.

In various embodiments, integrated implant 20 may be positioned withoutforming a pilot insertion path or bore 92. Integrated implant 20 may bepositioned by directly tapping the delivery rod until progress isprevented by the safety stop feature as described with respect to FIGS.1A-2B.

In the case of integrated implant 50 shown in FIGS. 2A and 2B, theimplant structure includes cutting broach 30 and cutting burr 38. Theaddition of cutting burr 38 allows for elimination of creating a pilotbore 92 in the bone with a separate cannulated drill bit 90. Rather, thepilot bore 92 is generated by cutting burr 38 as part of integratedimplant 50. Hence, integrated implant 50 may be used to generate a pilotbore 92 at the same time the integrated implant is positioned throughthe one adjacent bone segment or region, through the intervening spaceor joint, and partially into the other adjacent bone segment or region.Integrated implant 50 may be simultaneously tapped into position whilethe pilot bore is being formed. (See FIG. 8D)

FIGS. 9-10 are, respectively, anterior and posterior anterior views ofthe human hip girdle comprising the sacrum and the hip bones (the rightilium, and the left ilium), the sacrum being connected with both hipbones at the sacroiliac joint (in shorthand, the SI-Joint). Elongated,stem-like integrated implant structures 20,50 like that shown in FIGS.1A and 2A (and the alternative embodiments) make possible the fixationof the SI-Joint (shown in anterior and posterior views, respectively, inFIGS. 9 and 10) in a minimally invasive manner. Integrated implantstructures 20, 50 may be effectively implanted through the use of twoalternative surgical approaches; namely, a lateral approach or apostero-lateral approach. Either procedure is desirably aided byconventional lateral and/or anterior-posterior (A-P) visualizationtechniques, e.g., using X-ray image intensifiers such as a C-arms orfluoroscopes to produce a live image feed that is displayed on a TVscreen.

FIGS. 11-13B are anatomic views showing, respectively, in pre-implantedperspective, implanted perspective, implanted anterior view, andimplanted cranio-caudal section view, the implantation of three implantstructures for the fixation of the SI-Joint using a lateral approach. Inone embodiment of a lateral approach (see FIGS. 11-13B), one or moreintegrated implant structures 20, 50 are introduced laterally throughthe ilium, the SI-Joint, and into the sacrum. This path and resultingplacement of the integrated implant structures 20, 50 are best shown inFIGS. 12-13B. In the illustrated embodiment, three integrated implantstructures 20, 50 are placed in this manner. Also in the illustratedembodiment, the integrated implant structures 20, 50 are triangular incross section, but it should be appreciated that integrated implantstructures of other cross sections as previously described may be used.

Before undertaking a lateral implantation procedure, the physicianidentifies the SI-Joint segments that are to be fixated or fused(arthrodesed) using, e.g., the Fortin finger test, thigh thrust, FABER,Gaenslen's, compression, distraction, and diagnostic SI joint injection.

Aided by lateral, inlet, and outlet C-arm views, and with the patientlying in a prone position (on their stomach), the physician aligns thegreater sciatic notches using lateral visualization to provide a truelateral position. A 3 cm incision is made starting aligned with theposterior cortex of the sacral canal, followed by blunt-tissueseparation to the ilium. From the lateral view, the delivery pin 26, aSteinmann Pin for example, with a pin sleeve (not shown), is startedresting on the ilium at a position inferior to the sacrum end plate andjust anterior to the sacral canal and at a shallow angle (e. g., 15° to20° off the floor, as FIG. 13B shows). In the outlet view, the deliverypin 26 should be parallel to the sacrum end plate or angled slightlyaway from the sacrum end plate. In a lateral view, the delivery pin 26should be posterior to the sacrum anterior wall. In the outlet, thedelivery pin 26 should be superior to the sacral inferior foramen andlateral of mid-line. This corresponds generally to the sequence showndiagrammatically in FIGS. 8A-B. A soft tissue protector (not shown) orflexible sheath 22 is desirably slipped over the delivery pin 26 andfirmly against the ilium before removing the pin sleeve. In the inletview, the trajectory of the delivery pin 26 must no penetrate theanterior sacral cortex before the patient's sagittal midline.

The pilot bore 92 may be drilled in the manner previously described overthe delivery pin 26 (and through the soft tissue protector or flexiblesheath), as illustrated in FIG. 8C. The pilot bore 92 may extend throughthe ilium, through the SI-Joint, and into the sacrum. The drill bit 90is then removed.

The integrated implant 20 is tapped into the pilot bore 92 over thedelivery pin 26 (and through the soft tissue protector or flexiblesheath). The integrated implant 20 with cutting broach 30 eliminates anadditional step that requires using a separate broach to create abroached bore with the desired profile for the integrated implantstructure 20.

As shown in FIGS. 11 and 12, a triangular integrated implant 20 may betapped through the soft tissue protector or flexible sheath over thedelivery pin 26 through the ilium, across the SI-Joint, and into thesacrum, until the proximal end of the integrated implant 20 is flushagainst the lateral wall of the ilium (see also FIGS. 13A-B). In variousembodiments, the delivery pin 26 and soft tissue protector or flexiblesheath are withdrawn, leaving the integrated implant 20 residing in thebroached passageway, flush with the lateral wall of the ilium (see FIGS.13A-B). In other embodiments, the proximal end of the integrated implant20 is left proud of the lateral wall of the ilium, such that it extends1, 2, 3, 4, or 5 mm outside of the ilium. This ensures that theintegrated implant 20 engages the hard cortical portion of the iliumrather than just the softer cancellous portion, through which it mightmigrate if there was no structural support from hard cortical bone. Thehard cortical bone can also bear the loads or forces typically exertedon the bone by the integrated implant 20. In various embodiments, thedelivery pin 26 may not be withdrawn but instead remains implanted withthe integrated implant. In the illustrated embodiment, two additionalintegrated implants 20 are delivered in this manner, as FIG. 12 bestshows.

In the case of integrated implant 50, the implant structure includescutting broach 30 and cutting burr 38. The addition of cutting burr 38allows for elimination of creating a pilot bore 92 in the bone with aseparate drill. Rather, the pilot bore 92 is generated by cutting bore38 as part of the insertion of integrated implant 50.

The integrated implants 20, 50 are sized according to the local anatomy.For the SI-Joint, representative integrated implants 20, 50 may range insize, depending upon the local anatomy, from about 30 mm to about 70 mmin length, and about a 7 mm inscribed diameter (i.e. a triangle having aheight of about 10.5 mm and a base of about 12 mm). The morphology ofthe local structures can be generally understood by medicalprofessionals using textbooks of human skeletal anatomy along with theirknowledge of the site and its disease or injury. The physician is alsoable to ascertain the dimensions of the integrated implant 20, 50 basedupon prior analysis of the morphology of the targeted bone using, forexample, plain film x-ray, fluoroscopic x-ray, or MRI or CT scanning, aswell as intraoperative sizing methods using provided instrumentation.

FIGS. 14A-D are anatomic views of implanted exemplary integratedimplants. The number of integrated implants to use within a patient mayvary. FIG. 14A illustrates two integrated implants 100 having across-sectional geometry resembling a bow-tie as shown in FIG. 5. Theintegrated implants of FIG. 14A are adjacent and are about the samesize. In various embodiments, more or fewer implants may be used.Integrated implants 100 may be inserted into bone in a manner similar tothat described with respect to FIGS. 11-12.

FIG. 14B illustrates two integrated implants 110 having across-sectional geometry resembling the shape of an I-beam as shown inFIGS. 6A-B. The integrated implants of FIG. 14B are adjacent and areabout the same size. Integrated implants 110 may be inserted into bonein a manner similar to that described with respect to FIGS. 11-12.

FIG. 14C illustrates two integrated implants 20 having a cross-sectionalgeometry resembling a letter “Z” as shown in FIG. 7L. The integratedimplants of FIG. 14C are adjacent and are about the same size.Integrated implants 20 may be inserted into bone in a manner similar tothat described with respect to FIGS. 11-12.

FIG. 14D illustrates two integrated implants 20 having a cross-sectionalgeometry resembling a letter “V” as shown in FIG. 7M. The integratedimplants of FIG. 14D are adjacent and are about the same size.Integrated implants 20 may be inserted into bone in a manner similar tothat described with respect to FIGS. 11-12.

The integrated implant structures can obviate the need for autologousgrafts, bone graft material, additional pedicle screws and/or rods,hollow modular anchorage screws, cannulated compression screws, cages,or fixation screws. Still, in the physician's discretion, bone graftmaterial and other fixation instrumentation can be used in combinationwith the integrated implants 20.

The integrated implants 20, 50 make possible surgical techniques thatare less invasive than traditional open surgery with no extensive softtissue stripping and no disc removal. The assemblies make possiblestraightforward surgical approaches that complement the minimallyinvasive surgical techniques. The profile and design of the integratedimplants 20 minimize rotation and micro-motion. Rigid integratedimplants 20 made from titanium provide immediate post-op fusionstability. A bony in-growth region comprising a porous plasma spraycoating with irregular surface supports stable bone fixation/fusion. Theintegrated implants 20 and surgical approaches make possible theplacement of larger fusion surface areas designed to maximizepost-surgical weight bearing capacity and provide a biomechanicallyrigorous implant designed specifically to stabilize the heavily loadedsacroiliac joint.

Additional details pertinent to the present invention, includingmaterials and manufacturing techniques, may be employed as within thelevel of those with skill in the relevant art. The same may hold truewith respect to method-based aspects of the invention in terms ofadditional acts commonly or logically employed. Also, it is contemplatedthat any optional feature of the inventive variations described may beset forth and claimed independently, or in combination with any one ormore of the features described herein. Likewise, reference to a singularitem, includes the possibility that there are plural of the same itemspresent. More specifically, as used herein and in the appended claims,the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe examples described herein, but only by the plain meaning of theclaim terms employed.

What is claimed is:
 1. An integrated bone fusion implant deliveryassembly comprising: an elongated core having a central longitudinalaxis and a cross-section transverse to the central axis that includes arectilinear portion; and a bone cutting broach coupled to a distal endof the core, wherein the broach comprises a plurality of cutting edgeslocated on a tapered distal end of the broach.
 2. The assembly of claim1, further comprising a delivery rod coupled to a proximal end of thecore.
 3. The assembly of claim 1, further comprising a delivery pincoupled to the distal end of the core.
 4. The assembly of claim 1,further comprising a flexible sheath configured to surround the core andprotect against soft tissue damage.
 5. The assembly of claim 3, whereinthe delivery pin is permanently attached to the implant.
 6. The assemblyof claim 3, wherein the delivery pin is retractable.
 7. The assembly ofclaim 1, wherein the broach is formed from a wall of the core.
 8. Theassembly of claim 3, wherein the delivery pin is adapted to disengageand slip into an interior of the implant.
 9. The assembly of claim 4,wherein a pyramidal tip of the sheath is positioned at the distal end ofthe implant near the cutting broach.
 10. The assembly of claim 1,wherein the broach comprises teeth adapted to remove bone material asthe implant is inserted through bone.
 11. The assembly of claim 1,wherein the cross-section is triangular in shape.
 12. The assembly ofclaim 1, wherein the cross-section includes at least one apex.
 13. Amethod for fusing bone, comprising: identifying a bone site comprising afirst bone segment, a second bone segment, and a non-bony region betweenthe first and second bone segments; providing a bone fusion implantcomprising a core with a distal end and cutting broach on the distal endof the core; inserting a delivery pin through a first bone segment andinto a second bone segment, wherein the delivery pin is insertedpartially through the second bone segment; forming a pilot insertionbore in the first and second bone segments; and inserting the implantinto the first and second bone segments to thereby fuse the bonesegments, wherein inserting the implant advances the cutting broachthrough the bore and cuts at least one edge of the bore to accommodatethe implant shape.
 14. The method of claim 13, wherein the implantfurther comprises a cutting burr on the distal end of the core.
 15. Themethod of claim 14, wherein forming a pilot insertion bore comprisesadvancing the cutting burr into the first and second bone segments. 16.The method of claim 13, further comprising generating the pilotinsertion bore by tapping the implant into the first and second bonesegments.
 17. The method of claim 14, further comprising retracting thecutting burr into an interior of the implant.
 18. The method of claim13, wherein the first bone segment is the ilium and the second bonesegment is the sacrum.
 19. The method of claim 13, further comprisinginserting the implant laterally through the ilium and into the sacrum.20. The method of claim 13, wherein the broach comprises a plurality ofcutting edges located on a tapered distal end of the broach.
 21. Themethod of claim 13, wherein the broach comprises teeth adapted to removebone material as the implant is inserted through bone.
 22. The method ofclaim 13, wherein the broach comprises a series of at least threeprogressively larger broaching edges.
 23. The method of claim 13,wherein the core is elongated and comprises a central longitudinal axisand a cross-section transverse to the central axis that includes arectilinear portion.
 24. The method of claim 23, wherein thecross-section is triangular in shape.
 25. The method of claim 23,wherein the cross-section includes at least one apex.
 26. A method forfusing bone, comprising: identifying a bone site comprising a first bonesegment, a second bone segment, and a non-bony region between the firstand second bone segments; providing a bone fusion implant comprising acore with a distal end and cutting broach on the distal end of the core;inserting a delivery pin through a first bone segment and into a secondbone segment, wherein the delivery pin is inserted partially through thesecond bone segment; and inserting the implant into the first and secondbone segments to thereby fuse the bone segments, wherein inserting theimplant advances the cutting broach into the first and the second bonesegments and cuts at least one edge of a bore to accommodate the implantshape.